BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMS DELTEC

    MDR report key: 127785 · Received October 20, 1997

    Report

    Report Number
    127785
    Event Type
    Injury
    Date Received
    October 20, 1997
    Date of Event
    October 2, 1997
    Report Date
    October 17, 1997
    Manufacturer
    SIMS DELTEC
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    10/2/97 2320-PT. FOUND UNRESPONSIVE. RES. VOL. OF CADD ASSESSED TO BE LOWER THAN EXPECTED. ACTUAL VOL. UNKNOWN. 1 DOSE NARCAN GIVEN TO PT. PT RESPONDED IMMEDIATELY NO FURTHER DOSE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMS DELTEC CADD-PCA FRN SIMS DELTEC 5800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention